Green Banana Peel Extract for Melasma Treatment

NCT ID: NCT05031689

Last Updated: 2021-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-30

Study Completion Date

2021-08-10

Brief Summary

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To develop and evaluate a pharmaceutical formula based on green banana peel extract for the treatment of melasma.

Detailed Description

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Objective: to develop and evaluate a pharmaceutical formula based on green banana peel extract for the treatment of melasma. Methods: it will be a clinical, interventional, longitudinal study, random sampling, Sample will have 60 patients divided into two groups. In the Control Group, SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract will be used, and in the Study Group, in addition to SPF 30 sunscreen, pharmaceutical formulation containing green banana peel extract will be used. Patients will undergo treatment for 90 days, evaluated every 30 days through clinical evaluation and MELASQol.

Conditions

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Melasma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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SPF 30 and Placebo

Control Group will use SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract

Group Type PLACEBO_COMPARATOR

SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract

Intervention Type BIOLOGICAL

Control Group will use SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract

SPF 30 and pharmaceutical formulation with green banana peel

In Study Group, in addition to the SPF 30 sunscreen, a pharmaceutical formulation containing the extract of the green banana peel will be used.

Group Type ACTIVE_COMPARATOR

SPF 30 sunscreen and pharmaceutical formulation containing green banana peel extract

Intervention Type BIOLOGICAL

Study Group In addition to the SPF 30 sunscreen, a pharmaceutical formulation containing green banana peel extract will be used.

Interventions

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SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract

Control Group will use SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract

Intervention Type BIOLOGICAL

SPF 30 sunscreen and pharmaceutical formulation containing green banana peel extract

Study Group In addition to the SPF 30 sunscreen, a pharmaceutical formulation containing green banana peel extract will be used.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Female patients with melasma.
* Patients aged 18 years or over and 60 years or less.
* Patients who agree to participate in the study. -

Exclusion Criteria

* Patients who have other types of facial hyperchromia.
* Patients who give up, for any reason, to continue treatment.
* Patients who have any type of allergic reaction to the product.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universidade do Vale do Sapucai

OTHER

Sponsor Role lead

Responsible Party

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Adriana Rodrigues dos Anjos Mendonça

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adriana R dos Anjos Mendonça, PhD

Role: PRINCIPAL_INVESTIGATOR

Vale do Sapucaí University

Locations

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Vale do Sapucaí University

Pouso Alegre, Minas Gerais, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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Melasma

Identifier Type: -

Identifier Source: org_study_id

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